Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.

Study Overview

• Status: Unknown
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Qufeng Shengshi Fang and Loratadine; Drug: Loratadine

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyang Zhang, Doctor; Phone Number: (+86)13910769068; Email: zhangxymz@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital traditional Chinese medicine department
      • Contact: Xiaoyang Zhang, Doctor; Phone Number: (+86)13910769068; Email: zhangxymz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
• have allergic rhinitis in episodes.
• without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
• signed the informed consent form.

Exclusion Criteria:

• have severe deviation of nasal septum and nasal polyps.
• have nasal surgery or a history of cancer(tumor).
• have other serious illness or evidence of mental disorders.
• female in pregnancy and lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qufeng Shengshi Fang and Loratadine; Qufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials.	Drug: Qufeng Shengshi Fang and Loratadine; The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD; Drug: Loratadine; The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The control group patients are treated with Loratadine by oral, 10mg QD; Other Names: Claritin，WS1-(X-014)-2004Z
Active Comparator: Loratadine; Loratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness.	Drug: Qufeng Shengshi Fang and Loratadine; The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD; Drug: Loratadine; The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The control group patients are treated with Loratadine by oral, 10mg QD; Other Names: Claritin，WS1-(X-014)-2004Z

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement clinical symptoms of Allergen Rhinitis	Clinical symptoms of Allergen Rhinitis including Rhinocnesmus (0: No symptom；1：Intermittent；2：Formication but supportable；3：Formication and insupportable)，Sneeze (0: No symptom；1：3-5 times everyday；2：6-10 times everyday；3：>11 times everyday)，Rhinorrhea (0: No symptom；1：modicum；2：medium；3：mass)，Rhinobyon (0: No symptom；1：Conscious inspiratory；2：Intermittent；3：Mostly breathing through mouth)，Itchy eyes(0: No symptom；1：Pruritus but supportable；2：Need rub eyes occasionally；3：Need rub eyes frequently)，Racryorrhea (0: No symptom；1：With sneezing；2：between 1and 3；3：No sneeze also )，Itchy ears and palate(0: No symptom；1：Intermittent；2：Pruritus but supportable；3：Pruritus and insupportable). Assessing the change by comparing the symptom score before and after treatment.	0，4 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Function Examination	Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase （GGT）(U/L).	0，4 and 8 weeks
Renal Function Examination	Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).	0，4 and 8 weeks
Secretory immunoglobulin E Examination		0 and 8 weeks
Blood Routine Examination	Blood Routine Examination including white blood cell(WBC)(*10^9/L),monocyte number（MONO#）(*10^9/L)，monocyte percentage (MONO%)(%)，lymphocyte number（LY#）(*10^9/L)，lymphocyte percentage (LY%)(%)，neutrophil number（NEUT#）(*10^9/L)，neutrophil percentage (NEUT%)(%)，eosinophil number（NEUT#）(*10^9/L)，eosinophil percentage (NEUT%)(%)，red blood cell(RBC)(*10^12/L),hemoglobin(HGB) (g/L) and platelet count(PLT)(*10^9/L).	0，4 and 8 weeks
Urine Routine Examination	Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).	0，4 and 8 weeks
Fractional Exhaled Nitric Oxide Examination		0 and 8 weeks
Test of Cytokine	Cytokines is a kind of low-molecular-weight soluble protein, which has function of regulating inherent immunity and adaptive immunity, erythropoiesis, cell growth and injured tissue repair and others.In the study FlowCellect™ Mouse Th2 Intracellular Cytokine Kit (FCIM025124) and Th17 Intracellular Cytokine Kit (FCIM025125) will be used to compare the change on cytokine before and after treatment. This FlowCellect Mouse Cytokine Th2 Identification Kit for flow cytometry is designed to enable a researcher a quick & easy way to detect IL-4 expression in mouse Th2 CD4+ T-cells. This FlowCellect Mouse Cytokine Th17 Identification Kit for flow cytometry is designed to enable a researcher a quick & easy way to detect IL-17 expression in mouse Th17 CD4+ T-cells.	8 weeks
Test of Metabonomics	Metabolomics is the scientific study of chemical processes involving metabolites. Specifically, metabolomics is the "systematic study of the unique chemical fingerprints that specific cellular processes leave behind", the study of their small-molecule metabolite profiles. The metabolome represents the collection of all metabolites in a biological cell, tissue, organ or organism, which are the end products of cellular processes. Small molecules are the objects in Metabonomics which relative molecular mass is less than 1000.In the study NMR will be used as a way to assess the change on Metabonomics before and after treatment.	8 weeks
Test of Proteomics	The proteome is the entire set of proteins expressed by a genome, cell, tissue or organism at a certain time. More specifically, it is the set of expressed proteins in a given type of cell or organism, at a given time, under defined conditions. The term is a portmanteau of proteins and genome. Proteomics is the study of the proteome.In the study Mass Spectrometry will be used to compare the change on proteome before and after treatment.	8 weeks
Change of Exosomes	Exosomes as a utricle bubble structure are widely distributed in the peripheral blood, urine, saliva, ascites, amniotic fluid, and other body fluids. Exosomes carry different components, which are secreted by different cells, and these components give exosomes a variety in biological functions, such as potential biomarkers of immune cells, cancer, etc.In the study Ribo™ Exosome Isolation Reagent (for plasma or serum) will be used to compare the change on exosomes before and after treatment.	8 weeks
IncRNA Sequencing	Long non-coding RNAs (lnc RNAs) are non-protein coding RNA molecules with the sequence longer than 200 nucleotides. They are four times amount as protein coding transcripts and play important roles in diverse cellular regulations. Function identification of these lncRNAs remains challenging although abundant efforts were put in this field. In the study gene expression profile , named RiboArrayTM lncDETECTTM Human Array, will be used which are provided by RiboBio Co., Ltd.	8 weeks
Pulmonary function Examination	Pulmonary function Examination including forced expiratory volume in one second(FEV1)(L), forced vital capacity rate of one second(FEV1.0/FVC)(%), maximal mid-expiratory flow velocity(L/s), maximal expiratory flow in 50% vital capacity(L), maximal expiratory flow in 75% vital capacity(L) and peak expiratory flow rate(PEFR)(L/s).	8 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Xiaochun Liang, Doctor, Peking Union Medical College Hospital traditional Chinese medicine department

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: traditional Chinese medicine; Loratadine; questionnaire survey
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: JS-958

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No